New Study Validates Neoteryx's VAMS™ Technology for At-home Blood Collection In Monitoring HbA1c Levels of Diabetic Children
by Neoteryx, on July 19,2018
Wet-absorptive microsampling first to be used in home-sampling environment
TORRANCE, California – July 19, 2018 – Neoteryx LLC today announced research recently published in the official peer-reviewed scientific journal of the European Federation of Clinical Chemistry and Laboratory Medicine, Clinical Chemistry and Laboratory Medicine. The research found that analysis of samples extracted from the company’s VAMS™ technology showed almost perfect agreement with results obtained from venous blood samples for HbA1c levels on a Tosoh G8 analyzer. The investigator-initiated clinical research study took place from June 2017 to January 2018 at Ghent University Hospital in Belgium. The study included 100 patients and was approved by the school’s Ethics Committee.
“VAMS technology allows convenient at-home monitoring and is minimally invasive. It also offers efficiencies in the clinical setting, as providers will have blood results in hand before meeting with the patient,” said Dr. Christophe Stove, one of the study’s authors and director of the Laboratory of Toxicology at Ghent University. “Monitoring Type 1 diabetes in children is challenging for families. We’re constantly evaluating solutions to make the monitoring process more efficient. This study substantiates that wet-absorptive microsampling using Neoteryx’s VAMS technology provides clinically-viable results while simplifying patients’ lives, streamlining provider visits and easing the challenges of managing this disease.”
The objective of this study was to evaluate whether adjustments to the sample protocol would allow combining the simplicity of VAMS-based home sampling with clinically-acceptable results. In a paper originally published in 2017 on HbA1c analysis with the dried blood microsamples using VAMS, the researchers found the results deviated from the venous blood samples. The transition to wet-absorptive microsamples made the difference with a fixed volume of approximately 10 µL of blood using the absorbent tip of Neoteryx’s VAMS device.
“We are pleased with the results of Dr. Stove’s research and how the wet-absorptive tip yielded clinically-acceptable results with high patient satisfaction. This research underscores the importance of microsampling,” said Neoteryx Chief Scientific Officer Dr. Stuart Kushon. “The goal of Neoteryx is to allow for convenient blood collection at any time by anyone in any location. If we can do that for children managing their diabetes and make things easier for them, we are achieving that goal.”
Neoteryx LLC, based in Southern California, is focused on delivering simple, quantitative and automatable microsampling solutions for biological samples. Our class I exempt medical device, The Mitra Microsampler, facilitates convenient specimen collection and transportation of blood and other biological fluids to improve animal and human welfare, reduce laboratory costs and enable new models of care. Neoteryx’s customers work to advance pharmaceutical development, personalized medicine, biotechnology research and clinical diagnostics. For more information on Neoteryx, visit www.neoteryx.com or follow @neoteryx on Twitter.
The Mitra Microsampler class I medical device is for direct specimen collection and transportation of blood and other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA requirements.